MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM SCS IPG; SCS IPG

Model Number	3665
Medical Device Problem Codes	Premature End-of-Life Indicator (1480); Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Inadequate Pain Relief (2388)
Date of Event	09/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The implant of the patient¿s ipg is unknown.The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.
Event or Problem Description
It was reported (belgium) the device displayed the end of service (eos) message.The patient is not receiving therapy and will likely require surgical intervention.As a result, the physician explanted and replaced the patient¿s ipg with a new model, resolving the issue.
Additional Manufacturer Narrative
Corrected data: the patient had not lost stimulation , and this lack of stimulation was previously reported in error.It was reported that diagnostics indicated the elective replacement indicator (eri) triggered earlier than intended.The device had the appropriate level of battery voltage to provide therapy.The device was explanted and replaced.The device is included in the neuromodulation implantable pulse generator (ipg) inaccurate elective replacement indicator advisory notice issued by abbott on 12 september 2017.

• Brand Name: PROCLAIM SCS IPG
• Common Device Name: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 7918822
• Report Number: 1627487-2018-09324
• Device Sequence Number: 13815445
• Product Code: LGW
• UDI-Device Identifier: 05415067023247
• UDI-Public: 05415067023247
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2019
• Device Model Number: 3665
• Device Lot Number: 6000231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/07/2018
• Supplement Date Received by Manufacturer: 11/05/2018; 11/05/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 11/08/2018; 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1627487/09/12/2017/001-C
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other